ObesityPhase 2NCT00988845
Indole-3-Carbinol Effects on Estrogen Metabolism
A Phase 2 study testing Indole-3-carbinol in people with Obesity, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study will test a dietary supplement, indole-3-carbinol, for improving the estrogen profile in women across a range of body mass index. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Indole-3-carbinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jan 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- woman aged from 30 - 50 years
- regular menstrual cycle
Who cannot join
- taking hormone replacement or hormonal contraception
- thyroid disorder
- uncontrolled asthma
- BMI under 18.5
- allergy to cruciferous vegetables
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dietary Indole-3-Carbinol on Estrogen Metabolites Across a Wide Range of Body Mass Index: Implications for the Prevention of Endometrial Cancer in Obese Women
This study will test a dietary supplement, indole-3-carbinol, for improving the estrogen profile in women across a range of body mass index.
- Conditions
- Obesity
- Being tested
- Indole-3-carbinol
- Keywords
- dietary supplement, indole 3 carbinol, estrogen
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indole-3-carbinolDietary supplement
200 mg bid po X 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Indole-3-carbinol | Experimental | Not described Receives: Dietary Supplement: Indole-3-carbinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary 2/16-hydroxyestrone ratio
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2010
- Study completionJan 2014
Why it stopped: Slow accrual in the high BMI group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph P Connor, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988845
- Sponsor's protocol ID
- H-2009-0093
- Other IDs
- CC09709, A532800, SMPH\OBSTET & GYNECOL\OB-GYN
- Status last verified
- Apr 2015
- First submitted
- 1 Oct 2009
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Indole-3-Carbinol on Estrogen Metabolites Across a Wide Range of Body Mass Index: Implications for the Prevention of Endometrial Cancer in Obese Women
- ClinicalTrials.gov ID
- NCT00988845
- Acronym / sponsor ID
- H-2009-0093
- Conditions
- Obesity
- Keywords
- dietary supplement, indole 3 carbinol, estrogen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual in the high BMI group
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 2 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test a dietary supplement, indole-3-carbinol, for improving the estrogen profile in women across a range of body mass index.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indole-3-carbinol | Experimental | Dietary Supplement: Indole-3-carbinol |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- woman aged from 30 - 50 years
- regular menstrual cycle
Key exclusion criteria (5 listed)
- taking hormone replacement or hormonal contraception
- thyroid disorder
- uncontrolled asthma
- BMI under 18.5
- allergy to cruciferous vegetables
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indole-3-carbinol200 mg bid po X 8 weeks | Dietary supplement | Indole-3-carbinol |
Primary outcome
Change in urinary 2/16-hydroxyestrone ratio
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Slow accrual in the high BMI group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph P Connor, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indole-3-carbinol in people with Obesity, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow accrual in the high BMI group). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urinary 2/16-hydroxyestrone ratio (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.